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510(k) Data Aggregation
K Number
K965105Device Name
ELECTROPHYSIOLOGY TILT TABLE MODEL #9660
Manufacturer
U.S. IMAGING TABLES, INC.
Date Cleared
1997-01-30
(41 days)
Product Code
IXR
Regulation Number
892.1980Why did this record match?
Applicant Name (Manufacturer) :
U.S. IMAGING TABLES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
to position patients for a dia procedure employing some imaging technique or to position a patient for various treatments in or hospitals.
Device Description
the Electrophysiology 40 Tilt Table (Model 9660) and the Delux Model 9660 are designed for clinical applications such as: to position patients for a dia procedure employing some imaging technique or to position a patient for various treatments in or hospitals. This device is used by a physician or a health care professional; this device is not operated by a patient. This is a Class II device. As such this device has a Classification name as: Mobile Fluoroscopic Tilting Table, as described in 21 CFR Part 892. 11980. U.S. Imaging Tables, Incorporated has determined this device is substantially equivalent to a predicate medical device which is currently in commerce and is identified as: Deluxe "C" Arm Stretcher, Model 056-004, and is manufactured by Biodex Medical Systems, Inc. of Shirley New York.
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K Number
K965096Device Name
FLUOROVIEW SERIES FLUOROSCOPIC TABLES
Manufacturer
U.S. IMAGING TABLES, INC.
Date Cleared
1997-01-27
(38 days)
Product Code
IXR
Regulation Number
892.1980Why did this record match?
Applicant Name (Manufacturer) :
U.S. IMAGING TABLES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
to support a patient and facilitate a diagnostic procedure employing some imaging technique or to position a patient for various treatments in clinics or hospitals.
Device Description
This device, the Fluoroview "" Series Fluoroscopic Tables (Model 9680) and the Time Table C-Arm Stretcher. Model 9670 is designed for clinical applications such as: to support a patient and facilitate a diagnostic procedure employing some imaging technique or to position a patient for various treatments in clinics or hospitals. This device is used by a physician or a health care professional: this device is not operated by a patient. This is a Class II device has a Classification name as: Mobile Fluoroscopic Tilting Table, as described in 21 CFR Part 892.11980. U.S. Imaging Tables, Incorporated has determined this device is substantially equivalent to a predicate medical device which is currently in commerce and is identified as: Deluxe "C" Arm Stretcher, Model 056-004. and is manufactured by Biodex Medical Systems. Inc. of Shirley New York.
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